1. Technical Field
The present invention generally relates to systems, methods, and computer readable media for managing regulatory information or data, and, more particularly, for managing regulatory data relating to the development and regulatory approval of a product.
2. Background
Market access is becoming more and more difficult in markets subject to product regulation, such as the healthcare environment. Pharmaceutical, biotechnology, and medical device companies are faced with high product development costs, tough competition, and extensive regulations. The rules and procedures for obtaining regulatory review and approval often change, as do the personnel within the regulatory agencies or authorities. At the same time, companies are under enormous pressure to obtain quick regulatory approval and to keep products in compliance.
Many of today's products require regulatory approval or authorization. For instance, pharmaceutical and biotechnology companies must obtain approval from a regulatory authority, such as the U.S. Food and Drug Administration (FDA), before a new drug can be marketed. Such companies may have regulatory affairs departments to manage all communications between the company and the various regulatory authorities with which it deals. The regulatory affairs department must also work with numerous other groups or divisions within the corporation, such as those responsible for quality control, research and development, and sales and marketing, to ensure that regulatory requirements are met in a coordinated fashion.
The volume of data that a regulatory affairs department must manage can be enormous. Indeed, a regulatory affairs department is often responsible for numerous products subject to regulation by a host of regulatory authorities throughout the world. The amount of regulatory data for such products can grow exponentially each year as communications with those authorities continue to evolve. Moreover, companies and regulatory authorities typically require that this regulatory data be kept readily available for authority inspections and business planning.
Often, however, the regulatory data is spread over various locations throughout a company. Persons within a regulatory affairs department must often use numerous individual manual systems to track data pertaining to the products for which they are responsible. Moreover, the regulatory data is often not easily tracked, accessed, or referenced with respect to a particular product. In such environments, locating collective information pertaining to key regulatory activities is complicated and enormously time-consuming.
Accordingly, there is a need for systems, methods, and articles of manufacture that can efficiently manage regulatory data in the healthcare industry. Moreover, there is a need for systems and methods that can manage regulatory data in the healthcare industry so that it can be tracked, e.g., with respect to a region, a particular product or group of products, a manufacturing site, a regulation, and so forth.